Home›Netherlands›FINAPRES MEDICAL SYSTEMS B.V.

FINAPRES MEDICAL SYSTEMS B.V.

Netherlands · Enschede

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 1 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States1 registration records, 6 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: FINAPRES MEDICAL SYSTEMS B.V.

FDA 510(k) clearances by year

22003 · K023723

12007 · K063111

12015 · K141460

12017 · K160967

12018 · K173916

FDA listed device types

Oximeter 1Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1Plethysmograph, Impedance 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173916	Finapres Nova Noninvasive Hemodynamic Monitor	2018-11-06
US	K160967	Finapres Nova Noninvasive Hemodynamic Monitor	2017-04-18
US	K141460	FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR	2015-03-20
CA	65923	FINOMETER	Class II
CA	65924	PORTAPRES AMBULATORY NONINVASIVE BLOOD PRESSURE MONITOR	Class II
CA	72093	FINOMETER MODEL-2 SYSTEM	Class II

FINAPRES MEDICAL SYSTEMS B.V.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies